Consumer Reports: Is acetaminophen a deadly pain pill?

Consumer Reports: Is acetaminophen a deadly pain pill?

Acetaminophen (Tylenol and generic) is renowned for its safety, but it is a dangerous medication, according to Consumer Reports. Almost 80,000 people per year are treated in emergency rooms because they have taken too much of it, and the drug is now the most common cause of liver failure in this country.

Though some of those tragedies stem from abuse, many are accidental. It's not just that people are careless. Advice to "take only as directed" doesn't cut it when the directions are confusing and conflicting. And with acetaminophen, they are exactly that. For example, the Food and Drug Administration has lowered the maximum per-pill dose of prescription acetaminophen, but it hasn't taken the same step for over-the-counter products. And OTC drugmakers have wildly different notions of what people can take: Some labels advise taking no more than 1,000 milligrams of acetaminophen daily; others set the limit almost four times as high.

And with acetaminophen, accidentally taking too much is all too easy. That's because it's the most common drug in the U.S., found as an ingredient in more than 600 OTC and prescription medications, including allergy aids, cough and cold remedies, fever reducers, pain relievers and sleep aids.

"All of this doesn't mean that everyone should avoid acetaminophen altogether," says Dr. Marvin M. Lipman, chief medical adviser for Consumer Reports. "But it does mean that the FDA should fulfill its role to protect consumers by taking strong steps to reduce the dangers, such as finally establishing consistent standards for acetaminophen."

It also means you need to know the risks, not only of acetaminophen, but also of drugs such as ibuprofen (Advil and generic), naproxen (Aleve and generic) and Celebrex. That last drug, now prescribed only under its brand name, should be available in the next year or so as a lower-cost generic called celecoxib. But like its nonprescription cousins, it poses serious risks to your heart and stomach when taken regularly.

DANGEROUS DOSES

When taken at recommended doses, acetaminophen is safe for pain relief for most people, even when used long term. But there's little margin for error. Exceeding the maximum recommended dose -- by even a little -- can prove toxic, especially to the liver.

It has long been known that large doses of acetaminophen taken at once can be fatal. But cumulative smaller doses totaling more than 4,000 milligrams (eight 500-milligram, or "extra strength," pills) can be just as dangerous, if not more so. People who took repeat doses of the medication -- for complaints such as headaches, muscle pain and toothaches -- that put them over the maximum daily amount were more likely to have brain, kidney and liver problems, and faced a greater risk of dying or needing a liver transplant than people who had taken a single, large overdose. That's according to a 16-year Scottish study of people treated in the emergency room published in 2011.

That same year, the FDA tried to reduce acetaminophen poisonings by limiting the prescription products to 325 milligrams per pill. The agency noted that higher doses don't relieve pain better and that people are more likely to overdose on them.

But the agency has not yet imposed the same limits for nonprescription products, even though they account for 80 percent of the acetaminophen taken in the U.S. No doubt, that pleased OTC drugmakers: "Extra strength" products with 500 milligrams of acetaminophen per pill are big sellers.

And because acetaminophen shows up in so many products, Consumer Reports says you need to check all drug labels for acetaminophen. Then make sure you stay below the safe upper limit when you combine the pills. And avoid acetaminophen altogether if you are at risk for liver disease or drink alcohol heavily, because that multiplies the dangers. If you regularly take the drug, watch for signs of liver damage, including dark urine, pale stools, upper-right abdominal pain and a yellowish tinge to the whites of the eyes.